title: International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.
mesh_terms: D001688:Biological Products / Q000592:standards*; D002626:Chemistry, Pharmaceutical; D003226:Congresses as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D015507:Drugs, Investigational / Q000592:standards*; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D007391:International Cooperation; D007564:Japan; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D015507:Drugs, Investigational